Mini-Ties
MINI-TIES.120" Assorted XL KIT
36manufacturers in China registered for this device type
33catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (14), Jiangsu (8), Shanghai (4). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Zhejiang Eksen Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 9 |
| Zhejiang Risheng Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 8 |
| Yancheng Denrum Medical Apparatus Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 5 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
Showing 12 of 36. All 36 manufacturers in China registered for Band, Elastic, Orthodontic
Record
| Listed by | Ortho Organizers, Inc., United States |
|---|---|
| FDA product code | ECI |
| Device type | Band, Elastic, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-21 |
| Record revised | 2025-12-30 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2020-07-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 400-501 | In distribution | |
| 400-534 | In distribution | |
| 400-503 | In distribution | |
| 400-524 | In distribution | |
| 400-509 | In distribution | |
| 400-502 | In distribution | |
| 400-533 | In distribution | |
| 400-508 | In distribution | |
| 400-512 | In distribution | |
| 400-525 | In distribution | |
| 400-506 | In distribution | |
| 400-504 | In distribution | |
| 400-519 | In distribution | |
| 400-532 | In distribution | |
| 400-500 | In distribution | |
| 400-527 | In distribution | |
| 400-507 | In distribution | |
| 400-542 | In distribution | |
| 400-510 | In distribution | |
| 400-505 | In distribution | |
| 400-535 | In distribution | |
| 400-500XL | In distribution | |
| 400-526 | Withdrawn | |
| 400-521 | Withdrawn | |
| 400-540 | Withdrawn | |
| 400-513 | Withdrawn | |
| 400-530 | Withdrawn | |
| 400-528 | Withdrawn | |
| 400-529 | Withdrawn | |
| 400-514 | Withdrawn | |
| 400-520 | Withdrawn | |
| 400-531 | Withdrawn | |
| 400-536 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Auradonics | Auradonics Incorporated | 743 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 312 |
| Conlin Molar Band | Ortho Arch Company Inc | 308 |
| Elastic Chain | Ortho Organizers, Inc. | 248 |
| Ligatures | American Orthodontics | 233 |
| 3M™ AlastiK™ | 3M Unitek | 220 |
| Morelli | Dental Morelli Ltda. | 207 |
| Mirabay | Mirabay Orthodontics Corporation | 185 |
| Orthometric Elastomerics – Chain | Orthometric – Industria E Comercio DE Produtos Medicos E Odontologicos Ltda | 182 |
| Maximum | Ortho Technology, Inc. | 177 |
| Halo Molar Band | Ortho Arch Company Inc | 177 |
| Colored Chain | American Orthodontics | 168 |
Showing 12 of 474. All products under Band, Elastic, Orthodontic
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.